To the civil society of Europe
Please support the Berlin Declaration 2012:
Stop hiding clinical trial data!
Many human beings have participated or are presently participating in clinical studies to help contribute to the progress of medical science. They voluntarily put their bodies at risk in the testing of experimental therapies to serve the common good. In contrast, the sponsors of such clinical studies seem to consider the clinical study reports as their private property and refuse access to these data, impeding the ability of independent scientists to analyze the safety and efficacy of medicines, as seen in the case of the influenza drug Tamiflu®.
The health and well-being of everyone are endangered if clinical study reports are continued to be hidden from independent scientists and from the public. Taxpayer money is wasted when it is spent on medicines that are ineffective, or worse. We want the new “Clinical Trials Regulation” currently being prepared by the EU Commission and the EU Parliament to implement the four demands of the Berlin Declaration 2012.
A coalition of Evidence-Based Medicine (EBM) and public health scientists, the chamber of physicians of Berlin[i], the anti-corruption organisation Transparency International[ii] and the Charité Universitätsmedizin Berlin[iii] gathered on the Charité Campus on September 6, 2012, for a public debate[iv] with Peter Doshi, a member of the Cochrane Collaboration review group on influenza antivirals (neuraminidase inhibitors) [v].
The organisers agreed to publish the Berlin Declaration 2012, an open call for action and petition aiming to reinstitute the integrity of scientific publishing, EBM, and public health decision making.
Berlin Declaration 2012
I hereby support the Berlin Declaration to reinstitute the Integrity of Scientific Publishing, Evidence-Based Medicine and Public Health Decision Making. We expect all politically accountable national and international bodies to
· install democratic, transparent and reliable mechanisms to prevent conflict of interest within regulatory and public health agencies and related expert committees.
· ensure all regulatory and norm-setting agencies (for example, the European Medicines Agency (EMA), World Health Organization (WHO), or the US Food and Drug Administration [FDA]) provide unencumbered public access to all scientific documents in their possession (appropriately de-identified) to encourage independent scientific evaluation.
· encourage unbiased publication of clinical trial results in the future by treating deliberate reporting biases as a form of research misconduct.
· urgently revise national and international pandemic influenza plans to avoid the waste of health resources such as stockpiling the drug oseltamivir (Tamiflu).
The petition will be submitted to the European Parliament to influence the currently considered Clinical Trials Regulation (http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-%2f%2fEP%2f%2fNONSGML%2bCOMPARL%2bPE-504.236%2b01%2bDOC%2bPDF%2bV0%2f%2fEN)
The European Parliament shall rule that open access to all clinical study reports and raw data is mandatory in the EU. The benefit of the regulation to the European people is to be proven by applying it to the Tamiflu case: would the new regulation have prevented the enormous waste of taxpayers money in a drug of unproven efficacy if it had been in place in the year 2002 when Tamiflu was licensed by the European Medicines Agency (EMA)?
Please sign the Berlin Declaration 2012 along with
Drug Commission of the German Medical Association (DCGMA), Berlin; Dr. Günther Jonitz, President of the Chamber of Physicians of Berlin; Jörg Schaaber on behalf of BUKO Pharma-Kampagne and on behalf of International Society of Drug Bulletins (ISDB), Bielefeld; Prof. Hajo Zeeb on behalf of the German Society of Epidemiology; Prof. Ansgar Gerhardus on behalf of the German Public Health Association; Prof. Günter Breithardt, Department of Cardiology and Angiology, University of Münster; Prof. Heinz Rothgang, Center for Social Policy, University of Bremen; Dr. Peter Morfeld, Institute and Policlinic for Occupational Medicine, Environmental Medicine und Preventive Research, University of Cologne and Institute of Epidemiology and Risk Assessment, Evonik Industries, Essen; Prof. Innes Asher, Department of Paediatrics: Child and Youth Health, The University of Auckland, New Zealand; Prof. Robert Beaglehole, University of Auckland, New Zealand; Prof. Julie Buring, Harvard Medical School, Harvard University, Boston, MA., Prof. Lloyd Chambless, Department of Biostatistics, University of North Carolina at Chapel Hill, N.C.; Prof. Peter Goetzsche, Nordic Cochrane Centre, Copenhagen; Dr. Christof Prugger, INSERM, Paris; Prof. Joel Lexchin, School of Health Policy and Management, York University, Toronto, Ontario; Prof. Roger Thomas, Family Medicine, University of Calgary, Alberta; Dr. Lucija Tomljenovic, Natural Dynamics Research Group, Vancouver, BC; Dr. Eva Vanamee, Mount Sinai School of Medicine, New York, NY; Prof. Wasim Maziak, Department of Epidemiology, Florida International University, Miami, Florida; Prof. Gary Wong, Department of Paediatrics and School of Public Health, Chinese University of Hong Kong; Prof. Hywel Williams, Centre of Evidence-Based Dermatology, University of Nottingham; Prof. Luis Garcia-Marcos, Department of Paediatrics, University of Murcia; Dr. Carsten Flohr, St. John`s Institute of Dermatology, St. Thomas`Hospital, London; Prof. Javier Mallol, Department of Paediatric Respiratory Medicine, School of Medicine, University of Santiago de Chile, Santiago de Chile; Dr. Viktoria Mönch, former Head of the University Pharmacy, Ludwig Maximilians University, Munich; Dr. Marcello Ricardo Paulista Markus, University of Greifswald; Dr. Johanna Keil, Wenckebach Hospital, Berlin; Dr. Matthias Burchardt, University of Education, Ludwigsburg; Prof. Joachim Gardemann, University of Applied Sciences, Münster; Prof. Jürgen Marten, Board Member of Transparency International, German Chapter, Berlin; Helga Ebel, Member of Transparency International, German Chapter, Aachen; Prof. Christoph Stein, Clinic of Anaesthesiology and Operative Intensive Care , Free University of Berlin, Charite Campus Benjamin Franklin, Berlin and Member of Transparency International, German Chapter; Prof. Joachim W. Dudenhausen, Department of Obstetrics and Gynecology, Weill Cornell Medical College, New York and Deputy Chief Medical Officer, Sidra Medical&Research Center, Doha, Qatar and Charite University Medicine Berlin. Dr. Peter Tinnemann, Institute of Social Medicine and Epidemiology, Charite University Medicine, Berlin; Dr. Angela Spelsberg, Comprehensive Cancer Center Aachen and Board Member of Transparency International, German Chapter; Prof. Gerd Antes, German Cochrane Centre, Freiburg; Dr. Wolfgang Wodarg, Board Member of Transparency International, German Chapter, Berlin; Prof. Ulrich Keil, Institute of Epidemiology and Social Medicine, University of Münster and Member of Transparency International, German Chapter; Dr. Peter Doshi, Johns Hopkins University, School of Medicine, Baltimore; Dr. Tom Jefferson, Cochrane Centre, Rome.
[v]Jefferson, Tom, Mark A Jones, Peter Doshi, Chris B Del Mar, Carl J Heneghan, Rokuro Hama, und Matthew J Thompson. 2012. „Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children“. Cochrane database of systematic reviews (Online) 1: CD008965. doi:10.1002/14651858.CD008965.pub3.
For more information see also BMJ Open Data Campaign (http://www.bmj.com/tamiflu)
The health and well-being of everyone are endangered if clinical study reports are continued to be hidden from independent scientists and from the public. Taxpayer money is wasted when it is spent on medicines that are ineffective, or worse. We want the new “Clinical Trials Regulation” currently being prepared by the EU Commission and the EU Parliament to implement the four demands of the Berlin Declaration 2012: Stop hiding clinical trial data!